Comparison of Tibolone and Raloxifene on Bone Mineral Density in Osteopenic Postmenopausal Women (P06090) (STEP)
This study has been completed.
Merck Sharp & Dohme Corp.
First Posted: February 5, 2007
Last Update Posted: June 26, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
Both tibolone and raloxifene have been demonstrated to prevent postmenopausal bone loss. During treatment with tibolone bone mineral density (BMD) of the spine has been shown to be increased between 1.8 and 5.8 % above baseline in two years, depending on the population studied. Since treatments aimed at prevention should ideally be used long-term, compliance with the treatment is crucial. Efficacy of and compliance with the two treatments will be measured and evaluated.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Multinational, Randomized, Double-Blind, Parallel Group Comparative Trial on the Effects of 2 Years Treatment With Tibolone (1.25 mg Org OD 14) and Raloxifene (60 mg) on Bone Mineral Density in Osteopenic Postmenopausal Women|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- Measure BMD to evaluate the effects of treatment on bone mineral density of the lumbar vertebrae L1-L4 [ Time Frame: At screening, after 52 weeks and 104 weeks ]
Secondary Outcome Measures:
- To measure the effects on hot flushes by using diary booklets [ Time Frame: Throughout trial and up to week 52 ]
- To measure the economic impact during the whole trial period by using Medical resource utilization forms [ Time Frame: Baseline and week 52 and 104 ]
- Bone mineral density of the total hip [ Time Frame: At screening, week 52 and week 104 ]
- A vaginal smear to determine vaginal atrophy [ Time Frame: At screening, week 52 and week 104 ]
- Biochemical markers of bone metabolism [ Time Frame: At baseline, week 12, week 24, week 52 and week 104 ]
- McCoy Female Sexuality Questionnaire, Short -Form to assess sexual functioning, Women's Health Questionnaire to assess quality of life, Health Utility Index Mark 2 and 3 (HUI2/HUI3) to confirm the health status [ Time Frame: At baseline, week 12, week 24, week 52 and week 104 ]
|Actual Study Start Date:||July 31, 2000|
|Study Completion Date:||February 15, 2005|
|Primary Completion Date:||February 15, 2005 (Final data collection date for primary outcome measure)|
2 years treatment with tibolone (1.25 mg Org OD-14)
Active Comparator: 2
2 years treatment with raloxifene (60 mg)
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